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Psychedelic

Psilocybin for Major Depressive Disorder

Phase 2
Waitlist Available
Led By Scott Aaronson, MD
Research Sponsored by Sheppard Pratt Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day -1) to three weeks post-dose.
Awards & highlights

Study Summary

This trial is testing whether psilocybin can help improve depressive symptoms in adults with bipolar disorder.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -1) to three weeks post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day -1) to three weeks post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemLead Sponsor
21 Previous Clinical Trials
7,794 Total Patients Enrolled
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,543 Total Patients Enrolled
Scott Aaronson, MDPrincipal InvestigatorSheppard Pratt Health System
3 Previous Clinical Trials
842 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study open to individuals over the age of 50?

"Eligible candidates must be of legal age and under 65 to participate in this medical trial."

Answered by AI

How many individuals is the research team looking to recruit for this experiment?

"Unfortunately, this trial has already closed its recruitment process. Initially posted on March 1st 2021 and last updated October 24th 2022, it is no longer accepting patients. However, there are currently 1383 trials for unipolar depression and 32 studies that involve Psilocybin with active patient recruitment programs available."

Answered by AI

To what extent are there potential health hazards associated with Psilocybin?

"Our team at Power has assigned Psilocybin a score of 2 on the safety scale, as there is clinical evidence suggesting its security but no records indicating its efficacy."

Answered by AI

Is enrollment open for this experiment?

"Based on the information available from clinicaltrials.gov, this trial is not actively recruiting any longer. It was initially launched March 1st 2021 and last updated October 24th 2022; however, 1415 other studies are currently looking for patients to participate."

Answered by AI

Who is the ideal demographic for this medical research?

"To take part in this medical trial, potential participants must have been diagnosed with unipolar depression and be of the ages 18 to 65. There is space for 15 people to join at present."

Answered by AI

Are there any precedents of Psilocybin trials in the medical literature?

"Presently, 32 clinical trials are investigating the potential of psilocybin, none of which have progressed to phase 3. While several studies for Psilocybin are centred in Vancouver, Washington, there is a total of 35 trial sites across the globe."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Illinois
Pennsylvania
Other
How old are they?
65+
18 - 65
What site did they apply to?
Sheppard Pratt
Sam Rudow
Sheppard Pratt Health System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

What questions have other patients asked about this trial?

Will this be effective for PTSD? Would the trial be able to fly me out to the hospital or can we do a zoom interview?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

To help and be helped. Antidepressants (fluoxotine) have stopped working. I want to explore what psilocybin can do for my PTSD and Major Depression.
PatientReceived 2+ prior treatments
I've suffered from MDD for over two decades. I've tried dozens of treatments, but none have brought more than partial relief.
PatientReceived no prior treatments
I have tried a few ssri’s which didn’t agree and am currently on lamictal for stabilization. Have tried ketamine IV for depression.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Sheppard Pratt: < 24 hours
  2. Sam Rudow: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Scott T. Aaronson, M.D 2021. "The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04433845.
All > Bipolar Disorder
~4 spots leftby Apr 2025
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